The company has already expressed virus like particles (VLP) of the following pandemic strains in plants: Singapore (H2N2), Anhui (H5N1), Vietnam (H5N1), Hong Kong (H6N1 and H9N2), Equine/Prague (H7N7), and of the seasonal strains New Caledonia (H1N1), Solomon Island (H1N1) and Brisbane (H1N1). Medicago is keeping health authorities informed on its work.
Medicago’s H5N1 pandemic VLP vaccine has shown to be immunogenic at doses as low as 5mcg in preclinical studies and provided 100% cross-protection to different strains of the H5N1 virus in an animal model.
The company’s plant-based manufacturing technology could deliver a vaccine, just one month after the identification of the genetic sequence from an emerging pandemic strain. This vaccine would then be tested in animals and humans and reviewed by Health Canada before it is produced on a commercial scale. Medicago recently had a preclinical trial application (CTA) meeting with Health Canada’s Biologics and Genetic Therapies Directorate.
Based on the outcome of the meeting, the company is finalizing preclinical studies and preparing to move ahead with the submission of a CTA for its lead H5N1 pandemic VLP vaccine and with final approval will initiate a Phase I clinical trial in the third quarter of 2009.